Julie Barrier Email and Phone Number

 Coordination of the preparation and maintenance of the company PV System Master Files facilitate the work of the QPPV Office and and the oversight of the QPPVs by developing appropriate Tools with Informatics Department conduct of projects to create and maintain continuous QPPV Office oversight, support to PV inspections

 Coordinating the preparation and maintenance of the worldwide annual planning of all Aggregate Safety reports as per International / Local Requirements for all Sanofi group entities (Pasteur, Genzyme, Zentiva, Sanofi Pharma) Coordinating the collection of key information from all stakeholders for appropriate PV leader’s assignment decisions by QPPV (Qualified Person for Pharmacovigilance in Europe) Coordinating the introduction/comments on any new international/local regulations related to PSR planning Focal point for the Heads of PV affiliates for questions related to PSRs planning (Support for Health Authority questions, Assessment Report)  Inspection/ Audit of matters related to planning and Distribution of PSUR Producing quarterly compliance reports related to PSRs distribution and submission  Integrating the PV systems of the newly acquired companies within the PSR planning Preparing quality documents and training materials for business areas Developing tools used to manage activities (SHARE, Sharepoint) Reviewing Safety Data Exchange Agreements between Sanofi and Global Partners.

 Defining strategy of regulatory registration in countries of Asia Pacific & Russia Coordinating Dossier preparation (new registration, Renewal, variation) Implementing local or international regulations within company  Implementing of internal processes within AP&R countries.

 Coordinating Dossier preparation (new registration, Renewal, variation) for France Preparing Variation Dossier of industrial change control, labelling changes